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U.S. Department of Health and Human Services

New Pediatric Labeling Information Database - Detail
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Pediatric Labeling Date:  02/06/2018
 
Trade Name:  Pristiq
 
Generic Name or Proper Name (*):  desvenlafaxine
 
Indications Studied:  Major Depressive Disorder (MDD)
 
Label Changes Summary:  *Safety and effectiveness have not been established in pediatric patients for the treatment of MDD. *Efficacy was not demonstrated in two adequate and well controlled, 8-week, randomized, double-blind, placebo-controlled, parallel group studies conducted in 587 patients 7 to 17 years for the treatment of MDD. *Antidepressants, such as Pristiq, increase the risk of suicidal thoughts and behaviors in pediatric patients. *Pristiq was associated with a decrease in body weight in placebo-controlled trials in pediatric patients with MDD. The incidence of weight loss was 22%, 14%, and 7% for patients treated with low dose Pristiq, high dose Pristiq, and placebo, respectively. *The risks associated with longer term Pristiq use were assessed in 6-month, open-label extension studies in pediatric patients 7 to 17 years with MDD. *Postmarketing study.
 
Product Labeling:  Labeling  Opens a new window
 
BPCA(B) and PREA(P):  B,P
 
Sponsor:  Wyeth
 
NNPS:  FALSE
 
Therapeutic Category:  Antidepressant
 
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